ClinicalTrials.gg
Not yet recruitingNCT07700329Updated Jul 14, 2026

A Study to Evaluate the Blood Levels, Safety, and Tolerability of BMS-986368 in Healthy Chinese Participants

A Phase 1 interventional study of BMS-986368 and BMS-986368-matching Placebo in Healthy Volunteers, sponsored by Celgene. Not yet recruiting. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-14.

Sponsored by Celgene (part of Bristol-Myers Squibb) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The purpose of the study is to evaluate the drug levels, safety and tolerability of BMS-986368 in healthy Chinese participants

02

Conditions studied

  • Healthy Volunteers

Keywords

  • BMS-986368
  • CC-97489
  • Healthy volunteers
  • Healthy Chinese participants
  • Pharmacokinetics
  • Safety
  • Tolerability
  • FAAH inhibitor
  • MAGL inhibitor
  • Phase 1
03

In context

Lead sponsor

Celgene is the lead sponsor of 428 studies on the registry; 12 are open to participants now.

Of its 104 completed or terminated interventional studies of FDA-regulated products, 30 (29%) have results posted.

First submitted after Celgene became part of Bristol-Myers Squibb.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants must be healthy male or non-pregnant and non-nursing female (as assigned at birth).
  • Participants must be of Chinese ethnicity (both biological parents should be ethnically Chinese).
  • Participants must have of 18.0 kg/m2 to 28.0 kg/m2, inclusive and body weight of ≥ 50 kg.

Exclusion criteria

Exclusion Criteria:

  • Participants must not have personal or first-degree family history of psychiatric disorder, including, but not limited to, schizophrenia, psychosis, bipolar disorder, major depressive disorder, generalized anxiety disorder, obsessive-compulsive disorder, and post-traumatic stress disorder. Participants with a history of anxiety may be enrolled at the discretion of the investigator.
  • Participants must not have an active or prior history of stroke, chronic seizures, or major neurological disorders or has first-degree family relative who was diagnosed with these disorders below the age of 65 years.
  • Other protocol-defined Inclusion/Exclusion criteria apply.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
16 participants (estimated)

Study arms

  • Experimental
    Cohort 1

    Drug: BMS-986368 · Other: BMS-986368-matching Placebo

  • Experimental
    Cohort 2

    Drug: BMS-986368 · Other: BMS-986368-matching Placebo

Interventions

  • Specified dose on specified days

  • OtherBMS-986368-matching Placebo

    Specified dose of specified days

06

What researchers measure

Primary outcomes

  1. Maximum observed concentration (Cmax)

    Time frame: Up to approximately Day 17

  2. Time of maximum observed concentration (Tmax)

    Time frame: Up to approximately Day 17

  3. Area under the concentration-time curve (AUC)

    Time frame: Up to approximately Day 17

Secondary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to approximately Day 44

  2. Number of participants with serious adverse events (SAEs)

    Time frame: Up to approximately Day 44

  3. Number of participants with clinically significant vital sign measurements

    Time frame: Up to approximately Day 17

  4. Number of participants with clinically significant 12-lead electrocardiogram (ECG) examinations

    Time frame: Up to approximately Day 17

  5. Number of participants with clinically significant laboratory assessments

    Time frame: Up to approximately Day 17

  6. Number of participants with treatment emergent suicidal ideation and behavious assessed by Columbia Suicide Severity Rating Scale (C-SSRS)

    Time frame: Up to approximately Day 17

  7. Number of participants with changes with anxiety as assessed by Beck Anxiety Inventory (BAI)

    Time frame: Up to approximately Day 17

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: See Plan Description

Access criteria: See Plan Description

Data sharing details ↗ · www.bms.com

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2027; primary completion for Feb 2027, 1 month later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 9, 2026
First posted
Jul 14, 2026
StartEst.
Jan 5, 2027
Primary completionEst.
Feb 23, 2027
CompletionEst.
Feb 23, 2027
Last update
Jul 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07700329
Lead sponsor
Celgene
Responsible party
Sponsor
First posted
Jul 14, 2026
Start date
Jan 5, 2027 (estimated)
Primary completion
Feb 23, 2027 (estimated)
Completion
Feb 23, 2027 (estimated)
Last update
Jul 14, 2026

Study contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Contact
Clinical.Trials@bms.com
855-907-3286
First line of the email MUST contain NCT # and Site #.
Contact
Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Irafamdastat

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